NCT00291980

A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.

A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Henogen · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.

Detailed description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will taken at each of these visits.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HB-AS02V vaccine	HB-AS02V (20µg HBsAg) will be administered at Month 0
BIOLOGICAL	HBVAXPRO vaccine	HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-02-15
• Last updated: 2008-08-28

Locations

28 sites across 3 countries: Belgium, Czechia, Hungary